Practice Management and RCM Billing Built for Clinical Research

Clinical research sites face a unique billing compliance challenge: every service performed during a clinical trial must be correctly classified as sponsor-billed (research-related, paid by the trial sponsor) or routine-care billed (standard of care, billable to the patient's insurance), based on a Medicare Coverage Analysis performed for each protocol. Errors in this classification create double-billing compliance violations that can trigger False Claims Act exposure, making accurate charge routing the single most critical billing function at a research site.

Each clinical trial protocol generates a coverage analysis document mapping every visit, procedure, and lab test in the study calendar to a billing designation - sponsor-paid, Medicare/insurance-billed as routine care, or both with cost-sharing - based on Qualifying Clinical Trial criteria and protocol-specific research procedures. A single patient enrolled in a trial may have some services on a given visit billed to the sponsor while other services on that same visit are billed to their insurance, and any service billed to both creates a compliance violation that must be prevented at the point of charge capture.